Notice of Funding Opportunity

Application due Monday, June 15, 2026

National Center on Birth Defects and Developmental Disabilities (NCBDDD) Division of Human Development and Disability

Understanding and Promoting Resources and Opportunities for People with Autism and Fragile X Syndrome (FXS) and their Families Across the Lifespan Opportunity number: CDC-RFA-DD-26-0025

Contents

Step 1: Review the opportunity 5 Basic information 6

Eligibility 11

Agency priorities 15

Program description 18

Step 2: Get ready to apply 55 Get registered 56

Find the application package 57

Help applying 57

Join the informational call 58

Step 3: Build Your Application 59 Application checklist 60

Application contents and format 62

Step 4: Understand Review, Selection, and Award 72 Application review 73

Award notices 74

Step 5: Submit Your Application 75 Submission requirements and deadlines 76

Step 6: Learn What Happens After Award 78 Post-award requirements and administration 79

Contacts and Support 82

Before you begin 4

Appendix A 85

Appendix B 89

Contents 2

Appendix C 91

Endnotes 93

Contents 3

Before you begin If you believe you are a good candidate for this funding opportunity, secure your SAM.gov and Grants.gov registrations now. If you are already registered, make sure your registrations are active and up-to-date.

SAM.gov registration (this can take several weeks) You must have an active account with SAM.gov. This includes having a Unique Entity Identifier (UEI).

See Step 2: Get ready to apply

Grants.gov registration (this can take several days) You must have an active Grants.gov registration. Doing so requires a Login.gov registration as well.

See Step 2: Get ready to apply

Apply by the application due date Applications are due by 11:59 p.m. Eastern Time on Monday, June 15, 2026.

To help you find what you need, this NOFO uses internal links. In Adobe Reader, you can go back to where you were by pressing Alt + Left Arrow (Windows) or Command + Left Arrow (Mac) on your keyboard.

Before you begin 4 https://sam.gov/ https://grants.gov/

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1:

Review the opportunity

In this step

Basic information 6

Eligibility 11

Agency priorities 15

Program description 18

Basic information Centers for Disease Control and Prevention (CDC)

National Center on Birth Defects and Developmental Disabilities (NCBDDD)

Division of Human Development and Disability

Understanding and promoting resources and opportunities to improve long-term outcomes for people with autism or fragile X syndrome and their families across the lifespan.

Have questions?

Go to Contacts and Support.

Key facts

Opportunity name:

Understanding and Promoting Resources and Opportunities for People with Autism and Fragile X Syndrome (FXS) and their Families Across the Lifespan

Opportunity number:

CDC-RFA-DD-26-0025

Assistance listing: 93.073

NOFO version: Original

Key dates

Informational call:

May 27, 2026

Optional letter of intent deadline:

June 1, 2026

Application submission deadline:

June 15, 2026

Expected award date:

August 31, 2026

Expected start date:

September 30, 2026

See Submit Your Application for other time frames that may apply to this NOFO.

Summary This NOFO aims to better understand the resources and opportunities that people with autism or FXS and their families need, in areas including education, transition into young adulthood, and services and supports. The goal is to reduce morbidity and mortality, as well as improve long-term outcomes including health and wellbeing.

CDC will fund three components under this NOFO.

You may apply for one or more components, as long as you meet the eligibility requirements for each.

Gathering data on services and needs

Component A: SPROUT surveillance project

Project

This surveillance project, the Survey to Promote Resources and Opportunities for aUtistic Teens and young adults (SPROUT), will utilize cohorts from the Study to Explore Early Development (SEED) Phases 1-3 (collected from 2007-2020),

• These were case-control studies of autism in children 2-5 years of age.

• SEED 1-3 participants will range from about 10-28 years of age during the data collection period.

Data collected

SPROUT will be comprised of caregiver and self-report surveys.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1: Review the opportunity 6 https://www.cdc.gov/autism/seed/index.html

• These surveys will offer unique information not available in other surveys, claims, or administrative data on:

◦ Service and support needs and the impact of co-occurring conditions on autistic people and their families.

◦ The educational, transitional, social, and/or vocational needs and experiences of autistic adolescents and young adults.

Goals

The data collected from this surveillance project will help inform ways to:

• Lessen individual, familial, and societal costs associated with autism.

• Reduce morbidity and mortality.

• Improve health and well-being.

Component B: FAST FORWARD surveillance project

Project

The Focus on Advancing Support and Transition with the Fragile X Online Registry With Accessible Research Database (FAST FORWARD) will employ clinic-based enrollment of eligible participants at three sites, with a recruitment goal of at least 200 eligible people with FXS per site.

Data collected

The project will collect data on:

• Timing of and barriers to diagnosis.

• Service and support needs and the impact of co-occurring conditions on people with FXS and their families.

• Educational, transitional, social, and vocational needs and experiences of people with FXS and their families.

Goals

The data collected from this surveillance project will help inform ways to:

• Lessen individual, familial, and societal costs associated with FXS.

• Reduce morbidity and mortality.

• Improve health and well-being.

Step 1: Review the opportunity 7

Component C: Creating resources, support, and strengthening capacity for people with FXS

Purpose

This activity improves access to evidence-based information, support, and services for people with FXS, their families, and their communities. It also strengthens the capacity among healthcare providers to appropriately support patients with FXS on a national level.

Strategies

• Create, disseminate, evaluate, and continually improve tailored communication, education programs, products, and tools.

• Promote use of evidence-based FXS information to people with FXS, their families, their communities, and healthcare providers across the United States.

Step 1: Review the opportunity 8

Funding details Funding type: Cooperative agreement

Expected awards: Up to 11

• Component A: Up to 7

• Component B: Up to 3

• Component C: 1

Period of performance: 5 years in 12-month budget periods.

Expected total program funding over the performance period: $18,000,000

• Component A: $12,000,000

• Component B: $5,000,000

• Component C: $1,000,000

• The number of awards is subject to available funds and agency and program priorities.

Funding strategy Funding details for Component A

• Expected total program funding over the performance period:

$12,000,000

• Expected total program funding per budget period: $2,400,000

• Expected awards: Up to 7

• Funding range per budget period: $230,000 to $650,000(direct and indirect costs) (Note: funding amount will be based on the number of eligible participants and number of SEED phases per site)

• We plan to award up to seven projects for a five-year period of performance, consisting of five 12-month budget periods.

The number of awards is subject to available funds and agency and program priorities.

Funding details for Component B

• Expected total program funding over the performance period: $5,000,000

• Expected total program funding per budget period: $1,000,000

• Expected awards: Up to 3

• Expected average award amount per budget period: $333,333

Step 1: Review the opportunity 9

• We plan to award up to three projects for a five-year period of performance, consisting of five 12-month budget periods.

The number of awards is subject to available funds and agency and program priorities.

Funding details for Component C

• Expected total program funding over the performance period: $1,000,000

• Expected total program funding per budget period: $200,000

• Expected awards: 1

• Expected average award amount per budget period: $200,000

• We plan to award one project for a five-year period of performance, consisting of five 12-month budget periods.

The number of awards is subject to available funds and agency and program priorities.

Step 1: Review the opportunity 10

Eligibility Eligible applicants Only these types of organizations may apply.

• State governments.

• County governments.

• City or township governments.

• Special district governments.

• Independent school districts.

• Public and state-controlled institutions of higher education.

• Native American tribal governments (federally recognized).

• Public housing authorities and Indian housing authorities.

• Native American tribal organizations, other than federally recognized tribal governments.

• Nonprofits having a 501(c)(3) status, other than institutions of higher education.

• Nonprofits without 501(c)(3) status, other than institutions of higher education.

• Private institutions of higher education.

• For-profit organizations other than small businesses.

• Small businesses.

• Faith-based organizations.

• Bona fide agents applying on behalf of state, territorial, local, and tribal government organizations.

Bona fide agents must submit documentation that demonstrates their arrangement with the eligible applicant. See attachments.

Step 1: Review the opportunity 11

Other required qualifying factors Component A: SPROUT To apply for Component A, you must document access to individual contact and eligibility data from participants in the Study to Explore Early Development (SEED) phases 1, 2, and/or 3. This is required to complete the data collection outlined in Component A.

Therefore, you must either:

• Be one of the original SEED entities that collected data from children ages 2-5 and their parents (and therefore can contact these individuals for the Survey to Promote Resources and Opportunities for aUtistic Teens and young adults (SPROUT)), or

• Document collaborative agreements to work with one or more of the original entities that collected the contact information from SEED participants (also called former SEED recipients) to reach SEED participants for this project. Applicants that do not provide documentation of a collaborative agreement will be considered non-responsive and will not move forward for review.

• Document access in an attachment labeled “Evidence of access to contact information (Component A)”.

Entities that originally collected contact information from SEED participants include:

• JFK Partners and University of Colorado School of Medicine, Anschutz Medical Campus (SEED 1-3)

• Johns Hopkins University and Kennedy Krieger Institute (SEED 1-3)

• Washington University (SEED 3)

• University of North Carolina at Chapel Hill (SEED 1-3)

• The Board of Regents at the University of Wisconsin System (SEED 3)

• Kaiser Permanente Division of Research and the California Department of Health Services (SEED 1-2)

• University of Pennsylvania School of Nursing and The Children’s Hospital of Pennsylvania (SEED 1-2)

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1: Review the opportunity 12 https://www.cdc.gov/autism/seed/index.html https://www.cdc.gov/autism/seed/index.html https://cdphe.colorado.gov/study-to-explore-early-development-seed https://cdphe.colorado.gov/study-to-explore-early-development-seed https://publichealth.jhu.edu/wendy-klag-center-for-autism-and-developmental-disabilities/projects https://fitzgeraldlab.wustl.edu/projects/research/ https://ncseed.org/ https://wiseed.org/

Component B: FAST FORWARD To apply for Component B, you must:

• Provide evidence of access to clinic-based samples of children, adolescents, and adults (ages 0-40 years) with FXS full mutation diagnosis.

• Demonstrate ability and capacity to collect data and access clinical records on a minimum of 200 unique people with FXS full mutation diagnosis.

Component C: Creating resources, support, and strengthening capacity for people with FXS To apply for Component C, you must:

• Demonstrate ability and capacity to identify and reach people with FXS and their families and communities, across the United States.

• Demonstrate ability and capacity to reach healthcare providers, specifically those treating FXS patients.

• Demonstrate ability and capacity to generate new communication materials and continually identify and update resources for healthcare providers treating and people with FXS and their families and communities.

• Demonstrate ability and capacity to quantify metrics of impact (for example, tracking and reporting how many people use the materials or benefit from them).

Responsiveness criteria We will review your application to make sure it meets these requirements.

These are the basic requirements you must meet to move forward in the competition. We won’t consider an application that:

• Is from an organization that doesn’t meet all eligibility criteria. See requirements in eligibility.

• Is submitted after the deadline.

• For Component A only: Does not include documentation of collaborative agreement (if not an original SEED entity).

• For Component B only: Does not describe having access to health records.

Step 1: Review the opportunity 13

See the application checklists to understand which elements of your application are part of the responsiveness criteria.

Application limits You must follow these limits on the number of applications your organization can submit.

Under this NOFO, you may submit only one application under your organization’s Unique Entity Identifier (UEI).

Cost sharing and matching funds This program has no cost-sharing requirement, meaning you do not need to contribute to the costs of this project.

If you choose to include cost-sharing funds, we won’t consider it during review. If you receive an award, we will include your voluntary commitment in the award, and you must report on the funds.

Post-award requirements

Before you apply, make sure you understand the requirements that come with an award.

See Step 6: Learn What Happens After Award for information on regulations that apply, reporting, and more.

Step 1: Review the opportunity 14

Agency priorities Required alignment with CDC priorities The recipient of this award must implement any funds awarded under this NOFO to effectuate program goals or agency priorities in accordance with the Centers for Disease Control and Prevention (CDC) Priorities when authorized (for a full description of the CDC Priorities, please follow the provided hyperlink).

Funded activities must:

• Align with CDC’s core priorities by demonstrating a commitment to gold-standard science, transparency, and evidence-based practices.

• Support CDC’s mission to protect Americans from infectious and chronic diseases, strengthen public health systems, and advance innovation in health data and infrastructure.

• Contribute to rapid, science-driven responses to health threats, promote global health leadership, and adhere to principles of integrity, accountability, and compliance with applicable laws and federal priorities.

Consistent with CDC’s values, in carrying out any project funded under this NOFO, the recipient must adhere to the following principles where consistent with the authority and scope of the award and its activities:

• A commitment to gold-standard science and ensuring trust, transparency, and credibility: To build trust and improve CDC’s ability to lead during health crises, CDC will increase transparency, be more accountable, and follow strict, gold-standard scientific practices that are open, unbiased, and based on clear evidence.

• A commitment to global leadership: With staff in 63 countries and supporting 20 more, CDC’s Global Health Center:

◦ Works to prevent disease and advance emergency response.

◦ Detect health threats early, sends response teams, trains health workers, and provides personal protective equipment, vaccines, and medicines.

◦ Test disease samples from around the world to prepare for flu and other serious outbreaks.

◦ Has strengthened systems to better protect people at home and abroad after the COVID-19 outbreak.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1: Review the opportunity 15 https://www.cdc.gov/about/cdc/index.html

• A commitment to ensuring rapid, evidence-based responses to crises:

During public health emergencies, ensuring rapid, science-driven responses is critical to minimizing harm, maintaining public trust, and restoring stability. To meet this goal, CDC must continue to strengthen its emergency response systems by:

◦ Streamlining internal processes.

◦ Improving risk communication strategies.

◦ Ensuring that laboratory capacity is fully equipped and tested—capable of rapidly developing and deploying scalable diagnostics during crises.

◦ Embedding structures for real-time learning, independent after-action reviews, and the application of lessons learned will ensure that each crisis response is smarter, faster, and more effective than the last.

• A commitment to vaccine safety and efficacy research: CDC will apply “gold-standard” science to all of its vaccine safety and effectiveness research. It will make vaccine data, research methods, and related datasets publicly available through simple data use agreements to improve transparency, accountability, and trust.

• A commitment to advancing our understanding of the causes of autism spectrum disorder (ASD), neurodevelopmental disorders (NDDs), and chronic disease: CDC conducts research and works with partners to better understand the causes of autism spectrum disorder, neurodevelopmental disorders, and chronic diseases. It will use new and existing data to study the rise in these conditions, including the increase in autism diagnoses from 1 in 150 to nearly 1 in 31 over the past 25 years.

• A commitment to modernizing public health infrastructure and enhancing our approach to health data: CDC will modernize public health infrastructure to create a faster, more efficient health system that can detect and respond to outbreaks in real time. This effort includes:

◦ Replacing data silos with integrated systems.

◦ Using advanced technology.

◦ Strengthening partnerships with states to ensure shared responsibility and strong local health data systems.

◦ Emphasizing collaboration across federal and state partners, resilient and adaptable systems, and accountability for funded programs to ensure they align with these priorities and federal requirements.

Step 1: Review the opportunity 16

• Conflicts of interest: CDC will not support funding programs with conflicts of interest and ensure its work is based on transparent, unbiased science.

• Immigration: CDC funds will not be used to support or encourage illegal immigration, consistent with federal law.

• Protecting life and the family: CDC funds will not be used to support elective abortions, consistent with the Hyde Amendment, and will promote maternal health, the dignity of life, and strong families.

• Ending disorder on America’s streets: CDC will prioritize evidence-based programs that reduce homelessness, drug use, and public disorder. It will support comprehensive services for people with serious mental illness and substance use disorder. CDC will not support housing first strategies, harm-reduction or safe consumption sites, or related activities. To the extent allowable by federal law, CDC intends to give priority to grantees in States and municipalities that have laws and policies that support and enforce CDC’s priorities.

• Gender ideology and protecting children [PDF]: CDC will not fund medical interventions for minors seeking gender transition and will define sex based on biological criteria.

• DEI: CDC will not support DEI initiatives based on group identity and focus on merit-based, evidence-driven approaches to improve health outcomes.

• Parental rights: CDC will support policies that protect parental authority, promote transparency, and give parents greater control over their children’s education.

The recipient must demonstrate ongoing compliance with the full description and listing of CDC values and priorities, in all programs that are authorized to advance them, through program design, implementation, reporting, and evaluation.

Failure to meaningfully align funded activities with the applicable requirements may result in corrective action, additional reporting requirements, or other enforcement actions consistent with federal grant regulations found at 2 CFR Part 200 and the terms and conditions of this award. The full CDC Priorities Statement can be found here: Centers for Disease Control and Prevention (CDC) Priorities.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1: Review the opportunity 17 https://opa.hhs.gov/sites/default/files/2025-11/gender-dysphoria-report.pdf

Program description Background Component A:

Autism is a developmental disability defined by social communication challenges and restricted and repetitive patterns of behaviors (American Psychiatric Association).[1] Autistic traits generally appear in the first few years of life but may not fully manifest until social demands exceed individual capacity[2]. People with autism have a wide range of skills and abilities and most (90%) have at least one co-occurring condition (e.g., anxiety, attention-deficit/hyperactivity disorder [ADHD], speech-language disorder).[3] [4]

In 2022, about 1 in 31 children age 8 had an autism diagnosis or special education classification documented in health or education records.[5]

CDC data on young children with autism to date Most data collection on autism have focused on young children.

• For instance, CDC conducted the Study to Explore Early Development (SEED) from 2006-2011 (SEED1), 2011-2016 (SEED2), and 2016-2021 (SEED3) to collect data on children ages 2-5 years with and without autism.

• Over 90 SEED papers have now been published, including analyses of differences among children with autism compared to other children; for example, regarding communication[6],[7], gastrointestinal issues[8],[9],[10], safety issues[11],[12],[13], self-injurious behaviors[14] [15], sensory challenges[16] [17] [18], and sleep problems.[19]

• There have also been analyses on issues related to receipt of services and supports for young children with autism and other developmental disabilities.[20],[21],[22],[23],[24]

The federal government identified a need to improve efforts to better understand lifespan issues among people with autism in a 2017 Report to Congress[25] and the Autism CARES Act of 2024[26]. However, according to the most recent portfolio analysis from the Interagency Autism Coordinating Committee (IACC)[27], lifespan issues continue to receive the least amount of funding among federal agencies (i.e., 4.3%).

Step 1: Review the opportunity 18

For these reasons, CDC implemented two follow up surveys of caregivers and/ or participants previously enrolled in one of three phases of SEED: SEED Teen pilot (2018-2021) and SEED Follow-Up (ongoing until June 2026).

CDC data on older children and adolescents with autism to date

SEED Teen (2018-2021)

• SEED Teen was a pilot study that surveyed families of more than 800 children who previously participated in SEED 1; the children were 12-16 years old at the time of SEED Teen data collection.

• Goals:

◦ Assess the health and healthcare needs of children with autism as they transition into adolescence.

◦ Understand early childhood factors related to adolescent health outcomes in children with autism.

Findings

Analyses of SEED Teen pilot data revealed areas of unmet healthcare and social needs for autistic adolescents.

• Autistic adolescents were more likely than population controls to have mental health problems, physical difficulties, and sleep problems.[28]

• They were also more likely to have an unmet medical or mental health service need.[28]

• In both groups, a small percentage of adolescents (autism, 7.5%;

population comparison, 14.1%) received recommended health care transition (transition) guidance.[28]

• Autistic adolescents were less likely than their peers to participate in sports, vocational activities, volunteer activities, or other organized activities, or receive a social invitation from friends in the last 12 months.[29]

• The largest absolute differences in activity engagement were with social invitations.[29]

◦ This highlights the considerable social isolation experienced by autistic adolescents, and the need for social supports.

Step 1: Review the opportunity 19

Analyses of SEED Teen pilot data also identify potential treatment targets for co-occurring conditions that could improve the lives of autistic adolescents.

• For instance, DD, sensory integration disorder, and speech-language disorder occurred in over 20% of autistic children in both preschool and adolescence.[30]

• Anxiety disorders, ADHD, intellectual disability, and learning disability also occurred in over 20% of autistic adolescents with ASD.[30]

• Significantly more autistic children vs. those with another DD in preschool gained diagnoses of ADHD, DD, sensory integration disorder, and speech-language disorder by adolescence.[30]

• Early childhood language abilities and symptoms like anxiety were significant predictors of adolescent communication difficulties.[31]

SEED Follow-Up (2021-2026) SEED Follow-Up was launched in 2021, and data are being collected until June 2026. These data will allow investigators to expand upon findings from SEED Teen and explore topics not included in that survey, like:

• Barriers to community or social participation.

• Changes in learning skills from preschool to adolescence.

• Self-reported suicidal thoughts and behaviors.

Both SEED Teen and SEED Follow-Up helped identify healthcare needs and experiences among adolescents with autism, yet gaps remain in how to best support adolescents and young adults with autism and their families.

• For instance, although SEED Teen and SEED Follow-Up survey data identify problems with service access (e.g., problems getting an appointment and issues related to cost) they did not probe how systemic interventions could help lessen these problems.

• Both surveys were over one hour long, and while these surveys collected information on a wealth of exposures and outcomes, participants recommend shortening future surveys.

◦ Shorter, more targeted surveys can still address areas identified by the autistic community as important.

• A dedicated focus to publish results faster allows data to more rapidly inform public health action.

Step 1: Review the opportunity 20

Components B and C:

Fragile X syndrome (FXS) is a genetic disorder caused by changes in a gene called fragile X messenger ribonucleoprotein 1 (FMR1).

• FMR1 usually makes a protein called Fragile X Messenger Ribonucleoprotein (FMRP) that is needed for brain development.

• People with FXS make little or no FMRP.

• FXS is the most prevalent known cause of inherited intellectual disability and the most common monogenic cause of autism.[32]

• Physical features of FXS include a narrow face with prominent jaw and forehead and large ears.

• Medical features can include dental crowning, otitis media, sinus infections, sleep disorder, and strabismus.

• Developmental features can include:

◦ Intellectual disability.

◦ Motor delays.

◦ Poor eye contact.

◦ Repetitive behaviors.

◦ Seizure disorder.

◦ Speech-language disorder.

◦ Symptoms of ADHD.[32],[33]

• FXS is typically diagnosed in early childhood when physical, medical, and developmental features are more recognized.[32]

• It is estimated that 1 in 7,000 males and 1 in 11,000 females have FXS.[34]

CDC FXS data to date CDC is working to learn more about FXS so that better approaches to intervention can be developed.

As part of this effort, CDC has funded four FXS data collection efforts:

• 2008-2011: The first project piloted an infrastructure to conduct data collection from people with FXS across multiple sites.

• 2011-2020: The second (2011-2015) and third (2015-2020) projects, Fragile X Online Registry With Accessible Research Database (FORWARD), developed and piloted the infrastructure for a registry and for longitudinal data collection.

Step 1: Review the opportunity 21

• 2021-2026: The fourth project, FORWARD-MARCH (Multiple Assessments for Research CHaracterization), built on the foundation of the first two projects and continued data collection to better characterize the natural history of FXS.

National public health priorities and strategies

Healthy People 2030 This NOFO supports various Healthy People 2030 objectives:

• Adolescent Health (AH)

◦ AH-01: Increase the proportion of adolescents who had a preventative health care visit in the past year

◦ AH-02: Increase the proportion of adolescents who speak privately with a provider at a preventative medical visit

• Disability & Health (DH)

◦ DH-01: Reduce the proportion of adults with disabilities who delay preventative care because of cost

◦ DH-03: Reduce the proportion of people with intellectual and developmental disabilities who live in institutional settings with 7 or more people

• Maternal, Infant, and Child Health (MICH)

◦ MICH-19: Increase the proportion of children and adolescents who receive care in a medical home

◦ MICH-20: Increase the proportion of children and adolescents with special healthcare needs who have a system of care

• Mental Health & Mental Disorders (MHMD)

◦ MHMD-02: Reduce suicide attempts by adolescents

◦ MHMD-08: Increase the proportion of primary care visits where adolescents and adults are screened for depression

• Sleep Health (SH)

◦ SH-03 and SH-04: Increase the proportion of adults (SH-03) and high school students (SH-04) who get enough sleep

This NOFO also supports the following Healthy People 2030 objectives that are in development or have baseline only data:

• DH-D01: Reduce anxiety and depression in family caregivers of people with disabilities, Step 1: Review the opportunity 22

• DH-02: Reduce the proportion of adults with disabilities who experience serious psychological distress,

• Early and Middle Child Workgroup – Development, EMC-D04: Increase the proportion of children and adolescents who get appropriate treatment for anxiety and depression, and

• Hearing and Other Sensory or Communication Disorders Workgroup, HOSCD-05: Increase the proportion of children and adolescents with communication disorders who have seen a specialist in the last year.

Other federal reports and priorities supported by this NOFO are:

• Autism Cares Act of 2024: PUBL180.PS

• IACC draft 2024 strategic plan: Draft Chapters of the 2024 IACC Strategic Plan Update

• US HHS 2017 Report to Congress: Young adults and transitioning youth with autism spectrum disorder

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1: Review the opportunity 23 https://www.congress.gov/118/plaws/publ180/PLAW-118publ180.pdf https://iacc.hhs.gov/meetings/iacc-meetings/2024/strategic-plan-update/september23/strategic_plan_update.pdf?ver=2 https://iacc.hhs.gov/meetings/iacc-meetings/2024/strategic-plan-update/september23/strategic_plan_update.pdf?ver=2 https://www.hhs.gov/sites/default/files/2017AutismReport.pdf https://www.hhs.gov/sites/default/files/2017AutismReport.pdf

Purpose Component A: SPROUT

• SPROUT will enroll caregivers and their adolescent or young adult children who previously completed SEED 1, 2, or 3. Prior participation in SEED Teen or the SEED Follow-up is not required.

• Data will be collected through two caregiver surveys and two self-report surveys over the 5-year funding period.

• Information will be collected on demographics, co-occurring conditions, and service, support, and other needs and experiences of autistic people and their families.

• Much of the information collected on SPROUT surveys is intended to be unique; e.g., not available from other sources, such as claims or administrative data.

• Data will guide policies and practices to increase access to services and supports, and improve health and other outcomes of autistic people and their families.

Component B: FAST FORWARD

• FAST FORWARD will enroll people aged 40 years or younger with full mutation FXS through one of the three participating U.S. clinics.

• Each clinic will recruit at least 200 eligible participants. Previous participation in FORWARD or FORWARD-MARCH is not required.

• Data will be collected through caregiver surveys (some surveys may be completed online) and from existing clinical records.

• Information will be collected on demographics, symptoms, co-occurring conditions, and service, support, and other needs and experiences of people with FXS and their families.

• Data will guide practices to increase access to services and supports, and improve health and other outcomes of people with FXS and their families.

Component C: Creating resources, support, and strengthening capacity for people with FXS

• This project will improve access to evidence-based information, support, and services for people with FXS, their families, and their communities.

• It will strengthen the capacity of healthcare providers across the United States to appropriately support patients with FXS.

Step 1: Review the opportunity 24

Activities will include dissemination of knowledge gained from previously funded data collections, such FORWARD-MARCH.

Approach Program logic model The following logic model includes the strategies and activities required under this NOFO.

The logic model also includes the program’s expected outcomes. Outcomes are the results that you intend to achieve. They usually show the intended direction of change, such as increase or decrease.

The asterisked ( * ) outcomes are those we expect you to achieve during the 5-year period of performance. You are required to report on these outcomes.

Not all outcomes apply to all strategies. The table shows how they apply. You will use these outcomes as a guide for developing performance measures.

Table: Component A Strategies and Outcomes

Component A Strategies

Short-Term Outcomes

Intermediate Outcomes Long-Term Outcomes

Strategy 1.

Collect and manage timely, unique data on people who participated in SEED 1-3.

All-site data set created that can be used for cross-sectional and/or longitudinal analyses.

Finalized all-site data set actively used for cross-sectional and/or longitudinal analyses.*

Improved capacity to support people with autism and their families:

• Lessened individual, familial, and societal costs associated with autism.

• Reduced morbidity and mortality for people with autism.

• Improved health and well-being for people with autism.

Strategy 2.

Translate data into high quality public health products.

Resource needs and opportunities for people with autism and their families identified.*

Knowledge of these resource needs and opportunities shared with organizations, professionals, and other stakeholders.

Strategy 3.

Disseminate public health information.

Partnerships strengthened with organizations that support people with autism and their families.*

CDC autism data actively used to inform public health action.

Step 1: Review the opportunity 25

Table: Component B Strategies and Outcomes

Component B Strategies

Short-Term Outcomes

Intermediate Outcomes Long-Term Outcomes

Strategy 1:

Collect and manage timely, unique data on people age 0-40 years with full mutation FXS.

All-site data set created that can be used for analyses.

Finalized all-site data set actively used for analyses.*

Improved capacity to support people with FXS and their families:

• Lessened individual, familial, and societal costs associated with

FXS.

• Reduced morbidity and mortality for people with FXS.

• Improved health and well-being for people with FXS.

Strategy 2:

Translate data into high quality public health products.

Resource needs and opportunities for people with FXS and their families identified.*

Knowledge of these resource needs and opportunities for people with FXS shared with organizations, professionals, and other stakeholders.

Table: Component C Strategies and Outcomes

Component C Strategies

Short-Term Outcomes

Intermediate Outcomes Long-Term Outcomes

Strategy 3.

Disseminate information to specific audiences.

Partnerships strengthened with organizations (i.e., groups providing disability, medical, and/or educational resources) that support people with FXS and their families.

Resource needs and opportunities identified for people with FXS, their families and their healthcare providers.*

FXS data actively used to guide public health action.

Knowledge of these resource needs and opportunities for people with FXS shared with organizations, professionals, and other stakeholders.

Improved capacity to support people with FXS and their families:

• Lessened individual, familial, and societal costs associated with

FXS.

• Reduced morbidity and mortality for people with FXS.

• Improved health and well-being for people with FXS.

Step 1: Review the opportunity 26

Strategies and activities This section elaborates on the strategies and activities described in the logic model and provides details about how we expect you to implement your program.

Component A Strategy 1. Collect and manage timely, unique data on people who participated in SEED 1-3.

• Activity 1: Recruit and enroll eligible SPROUT participants.

◦ Identify the eligible recruitment pool from SEED 1-3 participants.

◦ Find and verify contact information for eligible SEED 1-3 participants and send survey invitations. Conduct contact tracing as needed.

◦ Conduct enrollment calls for participants who have received an invitation within a specified timeframe.

• Activity 2: Collect survey data.

◦ Conduct two waves of survey data collection with eligible SEED 1-3 caregivers and their adolescent/young adult child. For each wave, use standardized methods to administer one caregiver survey and one adolescent/young adult survey, yielding up to four surveys in total. Each survey should take no more than 20-30 minutes to complete.

◦ Complete all data collection in the timeframe specified by CDC.

◦ Issue and track participant incentives upon completion of surveys.

The use of incentives is consistent with applicable grant regulations and guidance.

• Activity 3: Manage collected data.

◦ Implement REDCap data collection system, designed by CDC to ensure uniform data collection across site, including providing IT infrastructure and maintaining and updating local REDCap systems.

◦ Ensure effective user operation of REDCap data collection system, including:

▪ Training and supporting users.

▪ Managing user access and permissions.

▪ Utilizing local expertise for trouble shooting.

◦ Host and use R software for data management, provide R training for staff members if needed, and ensure local expertise for troubleshooting.

Step 1: Review the opportunity 27

◦ Provide staff training on:

▪ Confidentiality.

▪ Data collection and management procedures.

▪ Data quality assurance/control.

◦ Implement data access control as appropriate.

◦ Restrict data access to only investigators affiliated with SPROUT.

◦ Update Data Management Plan as needed and submit to CDC for annual review.

• Activity 4: Clean and share de-identified data.

◦ Clean survey data in R using CDC-developed data programs and ensure that all personally identifiable information is removed.

◦ Collaborate with CDC to test and facilitate data upload/exchange.

◦ Submit de-identified data to CDC via secure file transfer protocol

(SFTP).

Strategy 2. Translate data into high quality public health products.

• Activity 1: Collaborate on two CDC-led all-site data briefs that will be published and available publicly (i.e., pooled dataset with data from all sites).

◦ Data from the pooled dataset will be used to develop two all-site data briefs. Awardees will work with CDC and other participating sites to identify content for each data brief. Data briefs will be completed within one year of all-site survey data availability for each wave (Year 3 and Year 5).

• Activity 2: Develop two site-specific data briefs to be shared with local site participants and community.

◦ Awardees will work with CDC to develop data briefs focused on data from their site. Data briefs will be delivered within one year of survey data completion for each wave (Year 3 and Year 5).

• Activity 3: Develop two additional and timely public health products.

◦ Each site should work with CDC to identify and develop at least two additional public health products (using all-site or single site data) within the funding period, which can include but are not limited to:

▪ Easy-to-read summaries.

▪ Infographics.

▪ Publicly accessible peer reviewed publications.

Step 1: Review the opportunity 28

▪ Professional trainings using SPROUT data.

▪ Site-specific websites.

◦ Consistent with the Public Access to CDC Funded Publication Policy, all peer-reviewed publications funded by CDC must be made available to the public for free and full use with no embargo period regardless of number of CDC-affiliated authors.

Strategy 3. Disseminate public health information.

• Activity 1: Disseminate all-site and site-specific data briefs.

◦ Identify community partners who will help to disseminate data briefs publicly. For example:

▪ Adolescents.

▪ Young adults.

▪ Parents.

▪ Providers.

▪ Professionals.

◦ Specify methods for dissemination. For example:

▪ Health fairs.

▪ Partner newsletters.

▪ Provider clinics.

▪ Public webinars.

▪ Social media.

◦ Work with community partners to disseminate information and assess whether information is reaching the intended audience. For example:

▪ Number of people reached and demographics of audience.

▪ Clicks, downloads, shares.

▪ Media attention.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1: Review the opportunity 29 https://stacks.cdc.gov/pap

Component B Strategy 1. Collect and manage timely, unique data on people age 0-40 years with full mutation FXS.

• Activity 1: Recruit a minimum of 200 unique clinic-based participants aged 0-40 years with FXS full mutation diagnosis.

◦ Assemble and maintain appropriately trained study staff to conduct data collection, management, and tracking.

◦ Establish access to data sources including:

▪ Contact information.

▪ Clinical information.

▪ Genetic information.

◦ Confirm contact information and eligibility of individuals with FXS for recruitment.

◦ Provide survey to recruited individuals with FXS or their caregivers.

◦ Conduct enrollment telephone calls for eligible participants who have not responded to survey invitations within a specified timeframe.

◦ Meet with other site recipients and CDC’s coordinating staff regularly to discuss study progress and troubleshoot any problems with study implementation.

• Activity 2: Collect data.

◦ Use standardized methods to collect data from caregivers and existing clinical data.

◦ Perform medical record abstraction with clinician review.

◦ Ensure active participation and confirm or clarify missing data to increase data collection completion rates with the goal of about 50 participants per year with complete data collected.

◦ Monitor completion of data collection.

◦ Ensure data entry completeness into the secure REDCap system within timeframe specified by CDC.

◦ Issue participant incentives upon completion of surveys. The use of incentives is consistent with applicable grant regulations and guidance.

• Activity 3: Manage data collected.

◦ Implement REDCap data collection system including providing IT infrastructure and maintaining and updating local REDCap systems.

Step 1: Review the opportunity 30

◦ Ensure effective user operation of REDCap data collection system, including:

▪ Training and supporting users.

▪ Managing user access and permissions.

▪ Utilizing local expertise for trouble shooting.

◦ Host and use R software for data management, provide R training for staff members if needed, and ensure local expertise for troubleshooting.

◦ Provide staff training on:

▪ Confidentiality.

▪ Data collection and management procedures.

▪ Data quality assurance/control.

◦ Implement data access control as appropriate.

◦ Restrict data access to only investigators affiliated with study.

◦ Update Data Management Plan as needed and submit to CDC for annual review.

• Activity 4. Clean and share de-identified data.

◦ Clean survey data in R using CDC-developed data programs and ensure that all personally identifiable information is removed.

▪ Collaborate with CDC to test and facilitate data upload/ exchange.

▪ Submit de-identified data to CDC via secure file transfer protocol

(SFTP).

Strategy 2. Translate data into high quality public health products.

• Activity 1: Develop timely public health products.

◦ Work with CDC to identify and develop at least one public health product (all-site or single site), which can include but are not limited to:

▪ Easy-to-read summaries.

▪ Infographics.

▪ Publicly accessible peer reviewed publications.

▪ Professional trainings using FORWARD and FORWARD-MARCH data.

◦ Consistent with the Public Access to CDC Funded Publication Policy, all peer-reviewed publications funded by CDC must be made

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1: Review the opportunity 31 https://stacks.cdc.gov/pap available to the public for free and full use with no embargo period regardless of CDC-affiliated authors.

Component C Strategy 3. Disseminate information to specific audiences.

You must share developed materials back with CDC and incorporate current evidence for successful communication and dissemination in all activities proposed.

• Activity 1: For people with FXS and their families and communities, create, disseminate, evaluate, and continuously improve tailored FXS communication and programs, products, tools, and supports that fill a demonstrated need related to FXS.

◦ Identify FXS priorities, information gaps, and education, communication, and support needs.

◦ Seek and incorporate direct input from those with FXS and family members.

◦ Develop a dissemination plan that includes evidence-based communication channels and engagement strategies.

◦ Evaluate and continuously improve programs, products, and tools, including communication channels used for dissemination.

◦ Ensure all programs, products, and tools are responsive to demonstrated needs related to FXS.

▪ Adapt tools when needed.

▪ Provide evaluation plan and metrics annually.

• Activity 2: For healthcare providers, create, disseminate, evaluate, and continuously improve tailored FXS communication and programs, products, and tools that fill a demonstrated need related to FXS.

◦ Identify FXS priorities, information gaps, and education and communication needs for healthcare providers.

◦ Develop or adapt existing FXS training and education programs, products, and tools, and disseminate for healthcare providers.

◦ Develop a dissemination plan that:

▪ Is evidence-based.

▪ Is innovative.

▪ Addresses identified needs and priorities for healthcare providers.

▪ Provides continuing education credits when possible.

Step 1: Review the opportunity 32

◦ Evaluate and continuously improve all FXS programs, products, and tools and dissemination plan.

◦ Ensure all programs, products, and tools are responsive to diverse provider-types and communication needs.

▪ Adapt programs, products, and tools when needed.

▪ Provide evaluation plan and metrics annually.

Outcomes This section includes information about the outcomes we expect you to report progress on and achieve within the performance period.

We will measure your progress toward the following outcomes from the logic model:

Component A

• Finalized all-site dataset(s) (i.e., pooled datasets) will be provided to all participating sites for further analysis on special topics of interest. A subset of data provided may be made available for public use consistent with applicable law, and, for shared with CDC, CDC’s policies related to data privacy, confidentiality, and security. It is expected that any recipients of this funding opportunity will be able to comply with these terms and conditions.

• Identified resource needs and opportunities for people with autism and their families.

• Strengthened partnerships with organizations that support people with autism and their families.

Component B

• Finalized all-site data set (i.e., pooled datasets) will be provided to all participating sites for further analysis on special topics of interest. A subset of data provided may be made available for public use consistent with applicable law, and, for data shared with CDC, CDC’s policies related to data privacy, confidentiality, and security. It is expected that any recipients of this funding opportunity will be able to comply with these terms and conditions.

• Identified resource needs and opportunities for people with FXS and their families.

Step 1: Review the opportunity 33

Component C

• Strengthened partnerships with organizations that support people with

FXS and their families.

Work plan You must provide a work plan for your project. The work plan connects your performance outcomes, strategies and activities, and measures. It provides more detail on how you will measure outcomes and processes.

Table: Sample format

Activities you will implement

Progress or process measures

From the data, monitoring, and evaluation section.

Relevant period of performance outcomes

From the outcomes section.

Responsible position or party

Completion date

Strategy 1:

1.

2.

3.

Strategy 2:

1.

2.

3.

Step 1: Review the opportunity 34

Data, monitoring, and evaluation CDC strategy CDC collects and reports on indicators to measure progress toward achieving the activities and outcomes. CDC will also use results for program planning, improvement, accountability, and reporting. CDC will share the results with key parties.

CDC will work with you throughout the life of an award to ensure that all activities and expected outcomes align with your strategies and goals, and those of the U.S. government.

You should dedicate some of the award funds to evaluate and monitor the performance of your project. You and CDC will agree on the final funding amount, but we expect that you will dedicate approximately 5 to 10%…